Eligibility criteria and Enrollment of a Diverse Racial and Ethnic population in Multiple Myeloma Clinical Trials

Abstract

Narrow eligibility criteria may contribute to underrepresentation of racial and ethnic subgroups in cancer clinical trials. We conducted a retrospective pooled analysis of multicenter, global clinical trials submitted to the U.S. FDA between 2006-2019 to support approval of multiple myeloma (MM) therapies to analyze the rates and reasons for trial ineligibility by race and ethnicity in MM clinical trials. Race and ethnicity were coded per OMB standards. Patients flagged as screen failures were identified as ineligible. Ineligibility rates were calculated as a percentage of patients who were ineligible compared to the screened population within the respective racial and ethnic subgroups. Trial eligibility criteria were grouped into specific categories for analysis of reasons for trial ineligibility. Blacks (25%), and Other (24%) race subgroups had higher ineligibility rates compared to Whites (17%). Asian race had the lowest ineligibility rates (12%) among the racial subgroups. Failure to meet Hematologic Lab Criteria (19%) and failure to meet Treatment Related Criteria (17%) were the most common reasons for ineligibility among Blacks and were more common in Black patients compared to other races. Failure to meet Disease Related Criteria was the most common reason for ineligibility among White (28%) and Asian (29%) participants. Our analysis indicates that specific eligibility criteria may contribute to enrollment disparities for racial and ethnic subgroups in MM clinical trials. However, the small number of screened patients in underrepresented racial and ethnic subgroups limits definitive conclusions.